Cellfina System Disposable Procedure Kit CK1

GUDID 00840763100827

ULTHERA, INC.

Mechanical skin contouring system injection/transection set
Primary Device ID00840763100827
NIH Device Record Key21324312-25a5-430f-8a1d-d6e696fce20d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCellfina System Disposable Procedure Kit
Version Model NumberRev O
Catalog NumberCK1
Company DUNS010981554
Company NameULTHERA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840763100827 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OUPPowered Surgical Instrument For Improvement In The Appearance Of Cellulite

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-26
Device Publish Date2019-03-18

Devices Manufactured by ULTHERA, INC.

00840763101169 - Ulthera System Cart2024-05-29
10840763100107 - Cellfina System Procedure Kit (Single Package)2024-05-09
00840763101145 - Ulthera System Control Unit PRIME2024-04-18
00840763101152 - Ulthera System Handpiece2024-04-16
00840763100742 - Cellfina Motor Module Device and Package2020-02-03
00840763100025 - Ulthera System Transducer DS 7-3.0 2019-07-26
00840763100414 - Cellfina System Disposable Tray2019-07-26
00840763100520 - Cellfina System Disposable Tray2019-07-26

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